Vice President Quality and Regulatory Affairs

This job is posted on behalf of Clinical Dynamix, Inc. by Top Echelon.

Position Summary

Our Startup Client is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies.

This executive will have overall responsibility for establishing and maintaining a phase-appropriate Quality Management System, providing strategic regulatory leadership, and ensuring compliance across clinical development, manufacturing, testing, and external partners.

The VP will serve as a key member of the leadership team and will work closely with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external partners to advance programs through clinical development and toward commercialization.

The successful candidate should be highly hands-on and comfortable operating in a small, fast-paced biotechnology company. This role requires both strategic leadership and the ability to independently assess issues, make risk-based recommendations, and drive execution. The VP will hold independent Quality authority for product disposition and release, maintained separately from Manufacturing and Technical Operations.

Key Responsibilities

Quality Leadership

• Provide executive leadership and oversight for Quality Assurance and Quality Control.

• Establish, maintain, and continuously improve a phase-appropriate Quality Management System (QMS)

supporting clinical-stage cell therapy development.

• Ensure compliance with applicable GMP, GCP, GLP, and other relevant FDA regulatory requirements.

• Provide independent Quality oversight of manufacturing, testing, release, clinical supply, and vendor activities.

• Maintain appropriate Quality independence from Manufacturing and Technical Operations, including

independent authority for product disposition and release. Oversee:

– Deviations and investigations

– Change controls

– Out-of-specification / out-of-trend investigations

– Product complaints

– Document control

– Training systems

– Supplier qualification

– Internal and external audits

– Batch records

– Product disposition and release

– Quality risk management

• Ensure Quality systems evolve appropriately as the company progresses from early clinical development toward

later-stage development and commercialization.

• Establish clear Quality metrics and regularly communicate significant risks, trends, and remediation plans to

executive leadership.

RegulatoryAffairs Leadership

• Develop and execute the company's US regulatory strategy, with expansion into global regulatory activities as

programs advance.

• Serve as a primary strategic interface with the FDA and other regulatory authorities. Lead preparation and review of:

– IND submissions and amendments

– FDA information requests

– Meeting packages

– Annual reports

– Clinical protocol amendments

– Investigator's Brochures

– CMC regulatory submissions

– Safety-related regulatory communications

• Provide strategic guidance on regulatory pathways for cell therapy programs, including early clinical

development, dose escalation, manufacturing changes, comparability, and later-stage development.

• Partner closely with Clinical, CMC, Preclinical, and R&D teams to ensure regulatory strategy is integrated into

development plans.

• Translate regulatory feedback into clear, actionable internal plans.

• Maintain productive and transparent interactions with regulatory authorities.

CMC & Cell Therapy Regulatory Strategy

• Provide regulatory and Quality leadership for cell therapy manufacturing and CMC development. Partner with Technical Operations on:

– Manufacturing process development

– Process qualification and validation strategy

– Analytical method development and validation

– Specifications

– Stability programs

– Raw material controls

– Comparability

– Manufacturing site changes

– Technology transfer

– Supply chain controls

• Assess regulatory impact of manufacturing changes and determine appropriate submission and implementation

strategies.

• Ensure manufacturing controls and documentation are appropriate for the clinical stage while supporting

progression toward commercial readiness.

Clinical Quality

• Provide Quality oversight of clinical development activities.

• Ensure appropriate GCP systems and vendor oversight are established.

• Partner with Clinical Operations on qualification and oversight of CROs, clinical sites, laboratories, and other

service providers.

• Support inspection readiness as the clinical program expands.

Vendor & Consultant Oversight

• Establish a structured approach for qualification and oversight of CROs, CDMOs, testing laboratories,

consultants, and other critical vendors.

• Evaluate external recommendations independently and ensure that final Quality and Regulatory strategies

reflect the company's scientific, operational, and business objectives.

• Build sufficient internal expertise so that critical regulatory and Quality decisions are owned by the company

rather than outsourced to consultants.

• Manage external consultants selectively to supplement, rather than replace, internal leadership.

Organizational Leadership

• Build and mentor a high-performing Quality and Regulatory organization appropriate for the company's stage of

development.

• Lead and develop existing QA/QC personnel and establish clear roles, responsibilities, decision rights, and

escalation pathways.

• Recruit additional Quality and Regulatory personnel as the organization grows.

• Develop future leaders within the Quality organization.

• Promote a culture of accountability, scientific rigor, collaboration, and practical risk management.

• Work collaboratively across functions while maintaining appropriate Quality independence.

Qualifications

Required

• Bachelor's degree in life sciences, engineering, pharmacy, or related discipline; advanced degree preferred.

• Typically 15+ years of progressive experience in biotechnology, pharmaceutical, or cell/gene therapy

development, including significant leadership experience.

• Direct Quality and/or Regulatory leadership experience with cell therapy, gene therapy, or other advanced /

complex biological products — required.

• Demonstrated experience leading Quality and/or Regulatory functions in a clinical-stage biotechnology

company.

• Strong understanding of GMP requirements for clinical manufacturing.

• Experience with IND-stage programs and direct interaction with FDA.

• Demonstrated experience developing regulatory strategy and responding to FDA questions or information

requests.

• Strong knowledge of Quality systems, including deviation management, CAPA, change control, supplier

qualification, audits, and product disposition.

• Experience supporting clinical manufacturing and release of investigational products.

• Experience managing CROs, CDMOs, laboratories, and regulatory/Quality consultants.

• Ability to operate effectively in a small company where executives are expected to work both strategically and

hands-on.

Preferred

• Advanced degree (MS, PhD, PharmD, MD, or equivalent).

• Prior leadership experience specifically in cell therapy, regenerative medicine, xenotransplantation, or other

advanced biologic modalities.

• Experience supporting products from Phase 1 through later-stage clinical development.

• Experience establishing or significantly upgrading a Quality Management System in a growing biotechnology

company.

• Experience with regulatory strategy for manufacturing changes and comparability.

• Experience participating in FDA meetings and regulatory inspections.

• Experience preparing an organization for commercial-stage GMP requirements.

Leadership Profile

The ideal candidate will:

• Exercise independent scientific and regulatory judgment.

• Be comfortable challenging assumptions while remaining pragmatic and solution-oriented.

• Understand the distinction between regulatory requirements, regulatory precedent, and conservative industry

practice.

• Identify practical paths forward rather than simply identifying compliance risks.

• Communicate clearly with executives and technical teams.

• Be willing to make decisions with incomplete information while appropriately managing risk.

• Balance patient safety, regulatory compliance, development speed, and business priorities.

• Operate effectively without a large corporate infrastructure.

• Take ownership of issues and drive them through resolution.